Associate Director, Safety Analysis Scientist
Johnson & Johnson
Johnson & Johnson seeks an Associate Director, Safety Analysis Scientist to lead safety assessments for pharmaceutical products in development and on the market. The role involves scientific evaluation, regulatory compliance, and cross-functional collaboration within the Oncology division at multiple New Jersey and Pennsylvania locations.
Responsibilities
- Lead safety evaluations including data analysis, report writing, and stakeholder collaboration
- Ensure quality of safety assessments and regulatory documents with minimal revisions needed
- Support Safety Management Teams and assist Medical Safety Officers with key safety deliverables
- Conduct proactive safety data reviews and develop safety positions for aggregate reporting
- Serve as product expert and subject matter expert for audits, inspections, and health authority interactions
Requirements
- Advanced degree in life sciences, pharmacy, medicine, or related field
- Extensive experience in pharmaceutical safety assessment and pharmacovigilance
- Strong knowledge of regulatory requirements and safety documentation
- Demonstrated leadership and ability to work independently with minimal oversight
- Excellent written and verbal communication skills for regulatory interactions
- Experience collaborating with cross-functional teams on product safety strategies
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$137k - $235.75k
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